BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGORS

    MDR report key: 2953870 · Received February 1, 2013

    Report

    Report Number
    9612420-2013-00001
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K052385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE MADE VISUAL AND MICROSCOPIC ANALYSIS. THE VISUAL ANALYSIS SHOWS THAT THE SCREW IS BROKEN THROUGH DYNAMIC POWER. IN THE MICROSCOPIC ANALYSIS THE EXPLANTANTS SHOWS MARKS OF A FATIGUE FRACTUREL. THE SIGHTING OF THE PRODUCTION ORDER AND MATERIAL CERTIFICATES SHOWS NO MEANDERING.

    Description of Event or Problem · 1

    THE PATIENT WAS OPERATED WITH TANGORS. AFTERWARDS THERE WAS WORSENING OF THE DIAGNOSTIC FINDINGS. THEN THERE WAS MADE EXTENSION SURGERY. DURING THIS SURGERY THE BAR WAS REMOVED AND WITH THIS BAR ALSO THE HEAD OF THE SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43572 TANGORS TANGORS NKB ULRICH GMBH & CO. KG TANGORS WSA14700292

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization